ACRA-CUT— 510(k) K944311

Substantially Equivalent

Acra Cut, Inc.

FDA 510(k) clearance K944311 for ACRA-CUT, Substantially Equivalent on 1994-11-18. Applicant: Acra Cut, Inc.. Device class: 2.

Clearance details

Applicant: Acra Cut, Inc.
Product code: Code HBO
Device class: Class 2
Regulation: 21 CFR 882.4150
Advisory panel: Neurology
Date received: 1994-09-02
Decision date: 1994-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Acton, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HBO

K253814 — Raney Clips Kit2026-07-21
K050044 — MEDTRONIC CLIP GUN KIT2005-02-07
K033660 — STORZ RANEY SCALP CLIP, MODEL 1-20-004-052004-01-07
K012219 — SCALPFIX CLIP SYSTEM2001-07-31
K905433 — CODMAN DISPOSABLE SCALP CLIP APPLIER1991-02-21

More clearances from Acra Cut, Inc.

K032970 — ACRA-CUT XPRESS 1202003-12-08
K911812 — ACRA-CUT WIRE PASS DRILL1991-09-10
K911819 — ACRA-CUT NEUROLOGICAL SURGICAL DEVICE-POWERED1991-09-10
K910225 — BONE PAD REMOVER1991-02-12
K910226 — DURAL DISSECTORS1991-02-12

Data sourced from openFDA. This site is unofficial and independent of the FDA.