510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K860102Substantially Equivalent

Mod. Endoneedle Single-Use Pneumoperitoneum Needle

Endotherapeutics, Redwood City CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K860102 is the FDA 510(k) clearance record for MOD. ENDONEEDLE SINGLE-USE PNEUMOPERITONEUM NEEDLE, a class II device, cleared for Endotherapeutics on under FDA product code FHP (Needle, Pneumoperitoneum, Simple). FDA records list 7 510(k) clearances for Endotherapeutics, from to . As of , FDA records show no recalls naming K860102.

Clearance record

Decision date
Received
(33 days to decision)
Product code
FHP Needle, Pneumoperitoneum, Simple
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Endotherapeutics 654 Bair Island Rd., Redwood City CA
Third party review
No

Clearances, product code FHP

Trailing 12 months

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

FDA records show no clearances under product code FHP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FHP, 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