Atlas FDA

KARL STORZ FLEXIBLE GRASPING, BIOPSY FORCEPS, STONE BASKETS, DISLODGERS, SCISSORS, INJECTION CANNULAE, CLEANING BRUSHES

FDA 510(k) clearance K950434 · decided 1995-03-29

Clearance details

K-number
K950434
Device name
KARL STORZ FLEXIBLE GRASPING, BIOPSY FORCEPS, STONE BASKETS, DISLODGERS, SCISSORS, INJECTION CANNULAE, CLEANING BRUSHES
Applicant
KARL STORZ Endoscopy-America, Inc.
Decision
Substantially Equivalent
Date received
1995-02-02
Decision date
1995-03-29
Days to decision
55 days
Clearance type
Traditional
Product code
OCZ
Device class
2
Regulation number
876.1500
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Culver City, CA, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

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

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Photodynamic Diagnostic D-Light C System (P050027/S034)KARL STORZ Endoscopy-America, Inc.2025-10-01
KARL STORZ Photodynamic Diagnostic D-Light C (PDD) System (P050027/S033)KARL STORZ Endoscopy-America, Inc.2025-05-02
KARL STORZ Photodynamic Diagnostic D-Light C (PDD) System (P050027/S032)KARL STORZ Endoscopy-America, Inc.2024-09-27
KARL STORZ D-Light C PDD System (P050027/S031)KARL STORZ Endoscopy-America, Inc.2023-05-05
KARL STORZ D-Light C PDD System (P050027/S030)KARL STORZ Endoscopy-America, Inc.2022-03-17
KARL STORZ D-Light C PDD System (P050027/S028)KARL STORZ Endoscopy-America, Inc.2022-02-04
KARL STORZ D-Light C PDD System (P050027/S029)KARL STORZ Endoscopy-America, Inc.2021-10-13
D-Light C PDD System (P050027/S027)KARL STORZ Endoscopy-America, Inc.2021-01-08