Atlas FDA

OCZ

74 FDA 510(k) clearances · Product code

77 daysmedian time to decision
143 days90th percentile
74clearances measured

FDA profile

Official device name
Endoscopic Grasping/Cutting Instrument, Non-Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1500
Medical specialty
Gastroenterology, Urology
Flags
Third-party review eligible
FDA definition
To manually grasp stones, tissues or other objects through an endoscope. To manipulate, sample or cut tissues through an endoscope.
Adverse events (MAUDE)
2021: 20 · 2022: 33 · 2023: 25 · 2024: 37 · 2025: 34 · 2026: 18
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
KARL STORZ Endoscopic Accessories for Urology (K252800)Karl Storz SE & CO. KG2026-06-03
SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter (SC500230) (K242923)Envision Endoscopy2024-12-20
Single Use Grasping Forceps (K191900)Zhejiang Chuangxiang Medical Technology Co., Ltd.2020-03-27
Grasping Forceps (K152802)Micro-Tech (Nanjing) Co., Ltd.2016-01-21
Ensizor Endoscopic Scissors (K150939)Slater Endoscopy, LLC2015-06-08
ENSIZOR ENDOSCOPIC SCISSORS (K141058)Slater Endoscopy, LLC2014-08-01
ENDOSCOPIC SUTURE CUTTER (K133736)United States Endoscopy Group, Inc.2014-01-07
ENDOSCOPIC RETRIEVAL DEVICE (K120084)United States Endoscopy Group, Inc.2012-05-30
G-PROX EZ ENDOSCOPIC GRASPER (K103688)Usgi Medical2011-01-14
ENDOCHOICE GRASPING INSULATED AND ALIGATOR JAW FORCEPS MODEL AMHGFA, ENDOCHOICE GRASPING INSULATED AND RAT TOOTH FORCEPS (K101298)Endochoice, Inc.2010-08-05
MONDEAL ENDOSCOPIC TISSUE RECESSION AND RELEASE SYSTEM (K072684)Mondeal North America, Inc.2008-01-04
HYSAFE MICRO MODULAR FORCEPS AND SCISSORS SYSTEM (K051276)Richard Wolf Medical Instruments Corp.2005-10-28
XBO1-824-18/19/20 BIOPSY FORCEPS (K012074)The Olympus Optical Co.2001-09-25
FLEXIBLE ENDOSCOPIC SCISSORS (K010412)Telemed Systems, Inc.2001-04-02
TELEMED SYSTEMS RETRIEVAL BASKET (K974300)Telemed Systems, Inc.1997-12-19
TRI TALON RETRIEVAL FORCEPS (K973071)Medical Engineering Laboratory, Inc.1997-10-24
K&W 2-PIECE TAKE-APART INSTRUMENTS(VARIOUS) (K973259)Medical Creative Technologies, Inc.1997-09-10
STONE EXTRACTOR (K971123)Phx Technologies Corp.1997-06-27
COMEG OPTICAL STONE CRUSHING FORCEPS, COMEG VISUAL OBTURATORS FOR UROLOGY, COMEG OPTICAL BIOPSY FORCEPS (K971202)Comeg Endoskopie GmbH1997-05-27
T-RX RETRIEVAL FORCEPS (K970982)Tri-Med Specialties, Inc.1997-05-09
PILLING WECK 2 PIECE TAKE-APART INSTRUMENTS (K965176)Pilling Weck Group1997-03-04
OLYMPUS BASKET GRASPERS (UROLOGY) (K961611)Olympus America, Inc.1996-07-18
OLYMPUS FG SERIES GRASPING FORCEPS (K955066)Olympus America, Inc.1996-01-25
OLYMPUS BASKET GRASPERS (K955063)Olympus America, Inc.1996-01-22
OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS (K955051)Olympus America, Inc.1996-01-18
BLADE, SCALPEL & BLADE, HANDEL (K954536)Access Surgical Intl., Inc.1995-11-29
KARL STORZ FLEXIBLE GRASPING, BIOPSY FORCEPS, STONE BASKETS, DISLODGERS, SCISSORS, INJECTION CANNULAE, CLEANING BRUSHES (K950434)KARL STORZ Endoscopy-America, Inc.1995-03-29
GIP/MEDI-GLOBE GOREIGN BODY GRASPERS (K943476)Medi-Globe Corp.1994-12-15
BASICS ENDOSCOPY SYSTEM (K941464)Cox Medical Ent., Inc.1994-08-05
BIOPSY SCISSORS (K942030)Surgical Technologies, Inc.1994-06-27
GRASPING FORCEPS FLEXIBLE STONE DISLODGER (K930499)Endomedix1993-08-16
COX DISPOSABLE RETRIEVAL DEVICES (K923489)Cox Medical Ent., Inc.1992-09-23
BIOSPSY FORCEPS (K920762)Symbiosis Corp.1992-08-26
GRASPING FORCEPS (K914503)Surgitek Medical Engineering Corp.1991-12-05
CORPAK GRASPING FORCEPS (K902949)Corpak Co.1990-08-30
WILSON-COOK RETRIEVAL & GRASPING FORCEPS (K902400)Wilson-Cook Medical, Inc.1990-08-07
PORGES BIOPSY & FOREIGN BODY FORCEPS (K896502)Porges Corp.1990-01-22
WILTEK GRASPING FORCEPS (K894862)Wiltek Medical, Inc.1989-12-21
3-RING HANDLE, GRASP FORCEPS, LOOP RETRIE., BASKET (K894986)North American Sterilization & Packaging Co.1989-12-01
DIAFLEX GRASP FORCEPS/RETRIEVAL LOOP & CYTO BRUSH (K881332)Baxter Healthcare Corp1988-04-27
3 FRENCH FLEXIBLE BIOPSY FORCEPS (K881399)Cook Urological, Inc.1988-04-11
GASTROINTESTINAL FLEXIBLE BIOSPY FORCEPS (K873248)Medical Engineering Laboratory, Inc.1987-12-30
OVAL CUP BIOPSY FORCEP(23/5) USED W/GASTRO/SIGOIDO (K874016)Endovations1987-12-29
OVAL CUP BIOPSY FORCEP (MODEL 18/5) (K874012)Endovations1987-12-29
GRASPING TRIPOD FORCEP (MODEL 23/25) (K874006)Endovations1987-12-29
ALLIGATOR JAW GRASPING FORCEP (MODEL 23/125) (K874004)Endovations1987-12-29
HOLLOW ALLIGATOR GRASPING FORCEP (MODEL 18/12) (K874003)Endovations1987-12-29
RAT TOOTH GRASPING FORCEP (MODEL 23/20) (K874005)Endovations1987-12-29
OVAL CUP HOT BIOPSY FORCEP (MODEL C-52) (K874009)Endovations1987-12-29
ROUND CUP HOT BIOPSY FORCEP (MODEL D-52) (K874010)Endovations1987-12-29
OVAL CUP HOT BIOPSY FORCEP (MODEL B-51) (K874008)Endovations1987-12-29
OVAL CUP HOT BIOPSY FORCEP (MODEL A-51) (K874007)Endovations1987-12-29
OVAL CUP WITH NEEDLE BIOPSY FORCEP (MODEL 23/1) (K874014)Endovations1987-12-29
OVAL CUP BIOPSY FORCEP(23/5) USED W/COLONOSCOPE (K874013)Endovations1987-12-29
OVAL CUP WITH NEEDLE BIOPSY FORCEP (MODEL 23/1) (K874011)Endovations1987-12-29
HOLLOW ALLIGATOR GRASPING FORCEP (MODEL 23/12) (K874015)Endovations1987-12-29
FLEXIBLE BIOPSY FORCEP (K871809)Surgi-Aid Endoscopics, Inc.1987-06-18
(URETEROSCOPIC) STRICTURE SCAPEL OR KNIFE (K870355)Cook Urological, Inc.1987-04-01
VAN-TEC DOUBLE SHEATH GRASPING FORCEPS (K865087)Van-Tec, Inc.1987-03-25
DAVOL RETRIEVAL BASKETS & FORCEPS (K845017)C.R. Bard, Inc.1985-01-15
HOBBS MEDICAL POLYPECTOMY SNARE (K844074)Hobbs Medical, Inc.1985-01-03
POLYP-SAVER SLEVE (K840800)Jayco Pharmaceuticals1984-03-23
HOBBS MEDICAL RETRIEVAL BASKET (K833124)Hobbs Medical, Inc.1983-11-29
HOBBS MEDICAL GRASPING FORCEPS (K833125)Hobbs Medical, Inc.1983-10-31
LOOP RETRIEVER (K830802)Van-Tec, Inc.1983-04-28
SPIRAL STONE AND RETRIEVAL BASKETS (K820429)American Endoscopy, Inc.1982-04-08
M.R. ASSOC. BASKET RETRIEVERS (K800970)Mr Associates, Inc.1980-05-08
M.R. ASSOC. CANNULAS (K800969)Mr Associates, Inc.1980-05-08
M.R. ASSOC. TRIPOD GRASPING FORCEPS (K800972)Mr Associates, Inc.1980-05-08
M.R. ASSOC. W TYPE GRASPING FORCEPS (K800976)Mr Associates, Inc.1980-05-08
M.R. ASSOC. RAT TOOTH GRASP FORCEPS (K800968)Mr Associates, Inc.1980-05-08
M.R. ASSOC. ALLIGATOR GRASPONG FORCEPS (K800967)Mr Associates, Inc.1980-05-08
RETRIEVABLE FORCEPS (K792345)Mill-Rose Laboratory1979-12-20
FORCEPS, GRASPING (K760180)V. Mueller O.V. Baxter Healthcare Corp.1976-12-02

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Every clearance here is in the API, with alerts when new ones post.