510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K951148Substantially Equivalent

Obsti-Hook

Onli, Gahanna OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K951148 is the FDA 510(k) clearance record for OBSTI-HOOK, a class I device, cleared for Onli on under FDA product code HGE (Amniotome). FDA records list one 510(k) clearance for Onli. As of , FDA records show no recalls naming K951148.

Clearance record

Decision date
Received
(88 days to decision)
Product code
HGE Amniotome
Regulation
21 CFR 884.4530
Device class
Class I
Review panel
Obstetrics/Gynecology
Applicant
Onli 506 Wickham Way, Gahanna OH
510(k) summary
Summary
Third party review
No

Clearances, product code HGE

Trailing 12 months

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

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