Arthroscope Operative Knife Set

FDA 510(k) K771851 · Richard Wolf Medical Instruments Corp.

Substantially Equivalent

510(k) numberK771851

Submission

Device name
Arthroscope Operative Knife Set
Applicant
Richard Wolf Medical Instruments Corp.
Mchenry, IL, US
Received
September 29, 1977
Decision date
October 27, 1977
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HTS – Knife, Orthopedic
Device class
Class I (low risk)
Regulation
21 CFR 888.4540
Specialty
Orthopedic

Other 510(k)s with product code HTS

510(k)DeviceApplicantDecision
K930507Custom Orthopaedic Trays (Packs)HTS · Traditional Associated Medical Products Co.02/22/1994SE
K933921Acuflex Disposable KnivesHTS · Traditional Acufex Microsurgical, Inc.01/26/1994SE
K882525Spinal MicroknifeHTS · Traditional Karlin Technology, Inc.09/22/1988SE
K873714Banana Knife, Disposable #TM-1612HTS · Traditional Arthropedics, Inc.11/02/1987SE
K873713Triangular Knife, Disposable #TM-1611HTS · Traditional Arthropedics, Inc.11/02/1987SE
K873711Retrograde Knife, Disposable #TM-1613HTS · Traditional Arthropedics, Inc.11/02/1987SE
K873712Standard Knife, Disposable #TM-1610HTS · Traditional Arthropedics, Inc.10/15/1987SE
K842820Arthroscopy KnivesHTS · Traditional Medtech Industries, Inc.08/14/1984SE

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Questions and answers

When was Arthroscope Operative Knife Set cleared by the FDA?

Arthroscope Operative Knife Set (K771851) received a 510(k) decision of Substantially Equivalent on October 27, 1977, 28 days after the submission was received.

What is the product code of K771851?

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