510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K870662Substantially Equivalent

Model Skck Sterile Knob Cover Kit

Life-Tech Intl., Inc., Houston TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K870662 is the FDA 510(k) clearance record for MODEL SKCK STERILE KNOB COVER KIT, a class II device, cleared for Life-Tech Intl., Inc. on under FDA product code BXM (Stimulator, Nerve, Ac-Powered). FDA records list 68 510(k) clearances for Life-Tech Intl., Inc., from to . As of , FDA records show no recalls naming K870662.

Clearance record

Decision date
Received
(251 days to decision)
Product code
BXM Stimulator, Nerve, Ac-Powered
Regulation
21 CFR 868.2775
Device class
Class II
Review panel
Anesthesiology
Applicant
Life-Tech Intl., Inc. P.O. Box 36221, Houston TX
Third party review
No

Clearances, product code BXM

Trailing 12 months

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

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