510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K051487Substantially Equivalent

Drg Laryngeal Augmentation Implant Device

Doctor'S Research Group, Inc., Plymouth CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K051487 is the FDA 510(k) clearance record for DRG LARYNGEAL AUGMENTATION IMPLANT DEVICE, a class II device, cleared for Doctor'S Research Group, Inc. on under FDA product code KHJ (Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)). FDA records list 14 510(k) clearances for Doctor'S Research Group, Inc., from to . As of , FDA records show no recalls naming K051487.

Clearance record

Decision date
Received
(199 days to decision)
Product code
KHJ Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
Regulation
21 CFR 874.3620
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Doctor'S Research Group, Inc. 50 Altair Ave., Plymouth CT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KHJ

Trailing 12 months
1 clearance under product code KHJ in the twelve months to October 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KHJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260