Cleared Traditional

K800275 - CEBOTOME DRILL

K800275 is an FDA 510(k) clearance for CEBOTOME DRILL, manufactured by American Sterilizer Co.. The device is a Class 1 Orthopedic device with product code HSZ cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K800275 · American Sterilizer Co. · Orthopedic device
Download Printable Device Report (PDF)
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Feb 1980
Decision
12d
Days
Class 1
Risk

K800275 is an FDA 510(k) clearance for the CEBOTOME DRILL. Classified as Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment (product code HSZ), Class I - General Controls.

Submitted by American Sterilizer Co. (Mchenry, US). The FDA issued a Cleared decision on February 19, 1980 after a review of 12 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 878.4820 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all American Sterilizer Co. devices

FDA 510(k) Submission Details - K800275

510(k) Number K800275 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 1980
Decision Date February 19, 1980
Days to Decision 12 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
110d faster than avg
Panel avg: 122d · This submission: 12d
Pathway characteristics
Predicate-based equivalence.

HSZ Device Classification - Class 1, General Controls

Product Code HSZ Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4820
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - HSZ Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment

All 31
Devices cleared under the same product code (HSZ) and FDA review panel - the closest regulatory comparables to K800275.
CORB TM COUNTERROTATING BIOPSY NEEDLE
K811005 · Zimmer, Inc. · Jun 1981
OSTEO OSCILAIR
K803284 · Richard'S Medical Equip., Inc. · Jan 1981
ANSPACH INSTRUMENT CADDY
K801329 · The Anspach Effort, Inc. · Jun 1980
3M CEMENT REMOVER
K791056 · 3M Company · Jul 1979
SURGAIRTOME TWO
K781979 · American Sterilizer Co. · Dec 1978
WIREDRIVER
K772324 · American Sterilizer Co. · Jan 1978