Atlas FDA

DIAFLEX GRASP FORCEPS/RETRIEVAL LOOP & CYTO BRUSH

FDA 510(k) clearance K881332 · decided 1988-04-27

Clearance details

K-number
K881332
Device name
DIAFLEX GRASP FORCEPS/RETRIEVAL LOOP & CYTO BRUSH
Applicant
Baxter Healthcare Corp
Decision
Substantially Equivalent
Date received
1988-03-29
Decision date
1988-04-27
Days to decision
29 days
Clearance type
Traditional
Product code
OCZ
Device class
2
Regulation number
876.1500
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Santa Ana, 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
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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
Floseal Hemostatic Matrix, Floseal with Recothrom; Floseal Hemostatic Matrix, Floseal Fast Prep; 3 Floseal Hemostatic Ma (P990009/S077)Baxter Healthcare Corp2025-11-13
FLOSEAL MATRIX/FLOSEAL MATRIX HEMOSTATIC SEALANT/PROCEED HEMOSTATIC SEALANT (P990009/S076)Baxter Healthcare Corp2025-06-30
Floseal Hemostatic Matrix (P990009/S075)Baxter Healthcare Corp2025-01-30
Adept Adhesion Reduction Solution (P050011/S009)Baxter Healthcare Corp2024-08-23
Floseal Hemostatic Matrix, Floseal with Recothrom, Floseal Hemostatic Matrix, Floseal Fast Prep (P990009/S074)Baxter Healthcare Corp2024-08-15
Floseal Hemostatic Matrix (P990009/S073)Baxter Healthcare Corp2024-01-10
Floseal Hemostatic Matrix, Fast Prep, Floseal Hemostatic Matrix, RTS (P990009/S072)Baxter Healthcare Corp2023-12-12
Floseal Hemostatic Matrix, RT5 (P990009/S070)Baxter Healthcare Corp2023-02-02