510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K063688Substantially Equivalent

Surgical Irrigation System, Irrigation Tube

The Anspach Effort, Inc., Palm Beach Gardens FL / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K063688 is the FDA 510(k) clearance record for SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE, a class I device, cleared for The Anspach Effort, Inc. on under FDA product code HWE (Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment). FDA records list 60 510(k) clearances for The Anspach Effort, Inc., from to . As of , FDA records show no recalls naming K063688.

Clearance record

Decision date
Received
(35 days to decision)
Product code
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Regulation
21 CFR 878.4820
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
The Anspach Effort, Inc. 4500 Riverside Dr., Palm Beach Gardens FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HWE

Trailing 12 months

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

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