The Extractor I TM

FDA 510(k) K801327 · The Anspach Effort, Inc.

Substantially Equivalent

510(k) numberK801327

Submission

Device name
The Extractor I TM
Applicant
The Anspach Effort, Inc.
Mchenry, IL, US
Received
June 3, 1980
Decision date
June 9, 1980
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HWB – Extractor
Device class
Class I (low risk)
Regulation
21 CFR 888.4540
Specialty
Orthopedic

Other 510(k)s with product code HWB

510(k)DeviceApplicantDecision
K873710Magnetic Retriever, 1.7MM W/Luer Fitting TM-1350HWB · Traditional Arthropedics, Inc.11/02/1987SE
K870844Schultz Prosthesis Component Inserter ExtractorHWB · Traditional Warsaw Orthopedic, Inc.03/13/1987SE
K870083Ferray ExtractorHWB · Traditional Terray Manufacturing, Inc.02/26/1987SE
K780300Hip Plate Removal InstrumentHWB · Traditional Richard'S Medical Equip., Inc.02/28/1978SE

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Questions and answers

When was The Extractor I TM cleared by the FDA?

The Extractor I TM (K801327) received a 510(k) decision of Substantially Equivalent on June 9, 1980, 6 days after the submission was received.

What is the product code of K801327?

The FDA product code is HWB – Extractor, a Class I (low risk) device regulated under 21 CFR 888.4540.