Dexterity Pneumo Sleeve Set

FDA 510(k) K962147 · Medical Creative Technologies, Inc.

Substantially Equivalent

510(k) numberK962147

Submission

Device name
Dexterity Pneumo Sleeve Set
Applicant
Medical Creative Technologies, Inc.
Colmar, PA, US
Received
June 3, 1996
Decision date
July 9, 1996
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GCJ – Laparoscope, General & Plastic Surgery
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1500
Specialty
Gastroenterology, Urology

Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

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More from TroCare, LLC

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K973259K&W 2-PIECE Take-Apart Instruments(Various)OCZ · Traditional 09/10/1997SE
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Questions and answers

When was Dexterity Pneumo Sleeve Set cleared by the FDA?

Dexterity Pneumo Sleeve Set (K962147) received a 510(k) decision of Substantially Equivalent on July 9, 1996, 36 days after the submission was received.

What is the product code of K962147?

The FDA product code is GCJ – Laparoscope, General & Plastic Surgery, a Class II (moderate risk) device regulated under 21 CFR 876.1500.