510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K910875Substantially Equivalent

Endopath Disposable Pneumoperitoneum Needle

Ethicon, Inc, Somerville NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K910875 is the FDA 510(k) clearance record for ENDOPATH DISPOSABLE PNEUMOPERITONEUM NEEDLE, a class II device, cleared for ETHICON, Inc. on under FDA product code FDP (Apparatus, Pneumoperitoneum, Automatic). FDA records list 208 510(k) clearances for ETHICON, Inc., from to . As of , FDA records show no recalls naming K910875.

Clearance record

Decision date
Received
(18 days to decision)
Product code
FDP Apparatus, Pneumoperitoneum, Automatic
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
ETHICON, Inc. Rte. 22 W. P.O. Box 151, Somerville NJ
Third party review
No

Clearances, product code FDP

Trailing 12 months

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

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