510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K900956Substantially Equivalent

Gs-7100 Cholangiogram Clamp, 5Mm

Solos Endoscopy, Inc., Norcross GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K900956 is the FDA 510(k) clearance record for GS-7100 CHOLANGIOGRAM CLAMP, 5MM, a class I device, cleared for Solos Endoscopy, Inc. on under FDA product code GDJ (Clamp, Surgical, General & Plastic Surgery). FDA records list 21 510(k) clearances for Solos Endoscopy, Inc., from to . As of , FDA records show no recalls naming K900956.

Clearance record

Decision date
Received
(50 days to decision)
Product code
GDJ Clamp, Surgical, General & Plastic Surgery
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Solos Endoscopy, Inc. 6191 Atlantic Blvd. Suite 4, Norcross GA
Third party review
No

Clearances, product code GDJ

Trailing 12 months

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

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