510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K911272Substantially Equivalent

Endoscopic Needlholder Cat. Number 114705

Edward Weck, Inc., Research Triangle Pa NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K911272 is the FDA 510(k) clearance record for ENDOSCOPIC NEEDLHOLDER CAT. NUMBER 114705, a class II device, cleared for Edward Weck, Inc. on under FDA product code FHG (Bell, Circumcision). FDA records list 140 510(k) clearances for Edward Weck, Inc., from to . As of , FDA records show no recalls naming K911272.

Clearance record

Decision date
Received
(102 days to decision)
Product code
FHG Bell, Circumcision
Regulation
21 CFR 884.4530
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Edward Weck, Inc. P.O. Box 12600, Research Triangle Pa NC
Third party review
No

Clearances, product code FHG

Trailing 12 months

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

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