510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K990561Substantially Equivalent

Optical Forceps

Pilling Weck Surgical, Fort Washington PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K990561 is the FDA 510(k) clearance record for OPTICAL FORCEPS, a class II device, cleared for Pilling Weck Surgical on under FDA product code JEK (Forceps, Biopsy, Bronchoscope (Rigid)). FDA's definition for product code JEK 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 5 510(k) clearances for Pilling Weck Surgical, from to . As of , FDA records show no recalls naming K990561.

Clearance record

Decision date
Received
(81 days to decision)
Product code
JEK Forceps, Biopsy, Bronchoscope (Rigid)
Regulation
21 CFR 874.4680
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Pilling Weck Surgical 420 Delaware Dr., Fort Washington PA
510(k) summary
Summary
Third party review
No

Clearances, product code JEK

Trailing 12 months

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

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