510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K211358Substantially Equivalent

Implanter incl. Accessories

Guilin Woodpecker Medical Instrument Co., Ltd, Guilin, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K211358 is the FDA 510(k) clearance record for Implanter incl. Accessories, a class I device, cleared for Guilin Woodpecker Medical Instrument Co., Ltd. on under FDA product code EBW (Controller, Foot, Handpiece And Cord). FDA records list 14 510(k) clearances for Guilin Woodpecker Medical Instrument Co., Ltd., from to . As of , FDA records show no recalls naming K211358.

Clearance record

Decision date
Received
(567 days to decision)
Product code
EBW Controller, Foot, Handpiece And Cord
Regulation
21 CFR 872.4200
Device class
Class I
Review panel
Dental
Applicant
Guilin Woodpecker Medical Instrument Co., Ltd. Information Industrial Park, Guilin, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EBW

Trailing 12 months
2 clearances under product code EBW in the twelve months to October 2026, January 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code EBW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20262
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260