510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K102387Substantially Equivalent

Mediscope Compressiopn Staple and Accessories

Mediscope Manufacturing, Inc., Pompano Beach FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K102387 is the FDA 510(k) clearance record for MEDISCOPE COMPRESSIOPN STAPLE AND ACCESSORIES, a class II device, cleared for Mediscope Manufacturing, Inc. on under FDA product code JDR (Staple, Fixation, Bone). FDA records list one 510(k) clearance for Mediscope Manufacturing, Inc. As of , FDA records show no recalls naming K102387.

Clearance record

Decision date
Received
(427 days to decision)
Product code
JDR Staple, Fixation, Bone
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
Mediscope Manufacturing, Inc. 8282 Shadow Wood Blvd., Pompano Beach FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JDR

Trailing 12 months
2 clearances under product code JDR 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 JDR, 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 20261
October 20260