Atlas FDA

REPROCESSED SINGLE USE DEVICES BIOPSY FORCEPS

FDA 510(k) clearance K033593 · decided 2003-11-20

Clearance details

K-number
K033593
Device name
REPROCESSED SINGLE USE DEVICES BIOPSY FORCEPS
Applicant
Clearmedical, Inc.
Decision
Substantially Equivalent
Date received
2003-11-13
Decision date
2003-11-20
Days to decision
7 days
Clearance type
Traditional
Product code
NLU
Device class
2
Regulation number
876.4300
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Bellevue, WA, 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
REPROCESSED HOT BIOPSY FORCEPS (K050136)Sterilmed, Inc.2005-07-20
SISS REPROCESSED HOT BIOPSY FORCEPS, LAPAROSCOPIC, ENDOSCOPIC AND ELECTROSURGICAL SURGICAL INSTRUMENTS AND ACCESSORIES (K024011)Surgical Instruments Service and Savings, Inc.2002-12-19
VANGUARD REPROCESSED ELECTRIC BIOPSY FORCEPS (K011800)Vanguard Medical Concepts, Inc.2001-09-27

Recalls involving this device

No recalls on record reference this clearance.