510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K001217Substantially Equivalent

Inside View

Monadnock Optics, Inc., Huntingdon Valley PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K001217 is the FDA 510(k) clearance record for INSIDE VIEW, a class II device, cleared for Monadnock Optics, Inc. on under FDA product code GCM (Endoscope, Rigid). FDA records list one 510(k) clearance for Monadnock Optics, Inc. As of , FDA records show no recalls naming K001217.

Clearance record

Decision date
Received
(85 days to decision)
Product code
GCM Endoscope, Rigid
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Monadnock Optics, Inc. 1464 Holcomb Rd., Huntingdon Valley PA
510(k) summary
Statement
Third party review
No

Clearances, product code GCM

Trailing 12 months

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

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