510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K932853Substantially Equivalent

Pin Holders, Transfixing Pins, Ol Wires, Half Pins

Applied Osteo Systems, Inc., Walnut Creek CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K932853 is the FDA 510(k) clearance record for PIN HOLDERS, TRANSFIXING PINS, OL WIRES, HALF PINS, a class II device, cleared for Applied Osteo Systems, Inc. on under FDA product code JEL (Curette, Biopsy, Bronchoscope (Rigid)). FDA's definition for product code JEL reads: "If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at...". FDA records list 15 510(k) clearances for Applied Osteo Systems, Inc., from to . As of , FDA records show no recalls naming K932853.

Clearance record

Decision date
Received
(257 days to decision)
Product code
JEL Curette, Biopsy, Bronchoscope (Rigid)
Regulation
21 CFR 874.4680
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Applied Osteo Systems, Inc. 1243 Alpine Rd., Walnut Creek CA
510(k) summary
Summary
Third party review
No

Clearances, product code JEL

Trailing 12 months

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

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