Atlas FDA

Single Use Grasping Forceps

FDA 510(k) clearance K191900 · decided 2020-03-27

Clearance details

K-number
K191900
Device name
Single Use Grasping Forceps
Applicant
Zhejiang Chuangxiang Medical Technology Co., Ltd.
Decision
Substantially Equivalent
Date received
2019-07-16
Decision date
2020-03-27
Days to decision
255 days
Clearance type
Traditional
Product code
OCZ
Device class
2
Regulation number
876.1500
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Hanzhou, CN
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
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

Recalls involving this device

No recalls on record reference this clearance.