510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K801304Substantially Equivalent

Camloc Syringe Biopsy Kit

Johannah Medical Services, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K801304 is the FDA 510(k) clearance record for CAMLOC SYRINGE BIOPSY KIT, a class I device, cleared for Johannah Medical Services, Inc. on under FDA product code GEE (Brush, Biopsy, General & Plastic Surgery). FDA records list 4 510(k) clearances for Johannah Medical Services, Inc., from to . As of , FDA records show no recalls naming K801304.

Clearance record

Decision date
Received
(9 days to decision)
Product code
GEE Brush, Biopsy, General & Plastic Surgery
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Johannah Medical Services, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code GEE

Trailing 12 months

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

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