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FDA 510(k)

SURGASSIST SYSTEM; WIRELESS REMOTE CONTROL (COMPONENT); WIRED REMOTE CONTROL

K-Number: K020343 · 2002-04-10

ApplicantPower Medical Interventions, Inc.
Decision Date2002-04-10
Product CodeGDW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGASSIST SYSTEM; WIRELESS REMOTE CONTROL (COMPONENT); WIRED REMOTE CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Power Medical Interventions, Inc.. It received FDA 510(k) clearance on 2002-04-10 under 510(k) number K020343. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGASSIST SYSTEM; WIRELESS REMOTE CONTROL (COMPONENT); WIRED REMOTE CONTROL?

SURGASSIST SYSTEM; WIRELESS REMOTE CONTROL (COMPONENT); WIRED REMOTE CONTROL is a medical device that received FDA 510(k) clearance on 2002-04-10. The listed applicant is Power Medical Interventions, Inc.. The 510(k) number is K020343.

When did SURGASSIST SYSTEM; WIRELESS REMOTE CONTROL (COMPONENT); WIRED REMOTE CONTROL receive FDA 510(k) clearance?

SURGASSIST SYSTEM; WIRELESS REMOTE CONTROL (COMPONENT); WIRED REMOTE CONTROL received FDA 510(k) clearance on 2002-04-10, under 510(k) number K020343.

Who is the listed applicant for SURGASSIST SYSTEM; WIRELESS REMOTE CONTROL (COMPONENT); WIRED REMOTE CONTROL?

The FDA 510(k) record lists Power Medical Interventions, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SURGASSIST SYSTEM; WIRELESS REMOTE CONTROL (COMPONENT); WIRED REMOTE CONTROL?

The FDA product code for SURGASSIST SYSTEM; WIRELESS REMOTE CONTROL (COMPONENT); WIRED REMOTE CONTROL is GDW.

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Other records listing Power Medical Interventions, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K091215INTELLIGENT POWER UNIT, INTELLIGENT CONSOLE, INTELLIGENT DELIVERY SYSTEM, INTELLIGENT SURGICAL INSTRUMENTK083527INTELLIGENT ARTICULATING ENDOSCOPIC LINEAR CUTTER REVERSE WITH RELOADSK081826INTELLIGENT STRAIGHT AND ARTICULAR ENDOSCOPIC LINEAR CUTTERS, VASCULAR WITH RELOADS, MODELS I30V, I45V, 160V, IR30VK073001IDRIVES, IDRIVEC, IDRIVEFK073148IDRIVES, IDRIVEC, IDRIVEF WITH VASCULAR INDICATIONSK071708I45, I45S, I60, AND I60S

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Official Source

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