510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K982149Substantially Equivalent

Smith & Nephew Dyonics Microlaparoscope

Smith & Nephew, Inc., Andover MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K982149 is the FDA 510(k) clearance record for SMITH & NEPHEW DYONICS MICROLAPAROSCOPE, a class II device, cleared for Smith & Nephew, Inc. on under FDA product code HET (Laparoscope, Gynecologic (And Accessories)). FDA records list 572 510(k) clearances for Smith & Nephew, Inc., from to . As of , FDA records show no recalls naming K982149.

Clearance record

Decision date
Received
(84 days to decision)
Product code
HET Laparoscope, Gynecologic (And Accessories)
Regulation
21 CFR 884.1720
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Smith & Nephew, Inc. 160 Dascomb Rd., Andover MA
510(k) summary
Summary
Third party review
No

Clearances, product code HET

Trailing 12 months

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

FDA records show no clearances under product code HET in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HET, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260