510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K935070Substantially Equivalent

Grasping Forceps, Biopsy Forceps, Spoon Forceps

Karl Storz Endoscopy-America, Inc., Kennesaw GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K935070 is the FDA 510(k) clearance record for GRASPING FORCEPS, BIOPSY FORCEPS, SPOON FORCEPS, a class I device, cleared for KARL STORZ Endoscopy-America, Inc. on under FDA product code FCL (Forceps, Biopsy, Non-Electric). FDA records list 402 510(k) clearances for KARL STORZ Endoscopy-America, Inc., from to . As of , FDA records show no recalls naming K935070.

Clearance record

Decision date
Received
(92 days to decision)
Product code
FCL Forceps, Biopsy, Non-Electric
Regulation
21 CFR 876.1075
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
KARL STORZ Endoscopy-America, Inc. 1201 Roberts Blvd., Kennesaw GA
510(k) summary
Summary
Third party review
No

Clearances, product code FCL

Trailing 12 months

FDA records hold no clearances under product code FCL in the trailing twelve months.

FDA records show no clearances under product code FCL in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FCL, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260