510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K161086Substantially Equivalent

Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed Harmonic Shears with Adaptive Tissue Technology (23cm)

Sterilmed Inc, Plymouth MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K161086 is the FDA 510(k) clearance record for Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed Harmonic Shears with Adaptive Tissue Technology (23cm), a class II device, cleared for Sterilmed, Inc. on under FDA product code NUJ (Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed). FDA's definition for product code NUJ reads: "Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)". FDA records list 65 510(k) clearances for Sterilmed, Inc., from to . As of , FDA records show no recalls naming K161086.

Clearance record

Decision date
Received
(155 days to decision)
Product code
NUJ Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
Regulation
21 CFR 878.4400
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Sterilmed, Inc. 5010 Cheshire Pkwy., Plymouth MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NUJ

Trailing 12 months

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

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