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FDA 510(k)

VISITEC PRECISE-POINT

K-Number: K942234 · 1994-07-12

ApplicantVisitec Co.
Decision Date1994-07-12
Product CodeGAP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VISITEC PRECISE-POINT is the device name listed in this FDA 510(k) record. The listed applicant is Visitec Co.. It received FDA 510(k) clearance on 1994-07-12 under 510(k) number K942234. The device is classified under product code GAP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VISITEC PRECISE-POINT?

VISITEC PRECISE-POINT is a medical device that received FDA 510(k) clearance on 1994-07-12. The listed applicant is Visitec Co.. The 510(k) number is K942234.

When did VISITEC PRECISE-POINT receive FDA 510(k) clearance?

VISITEC PRECISE-POINT received FDA 510(k) clearance on 1994-07-12, under 510(k) number K942234.

Who is the listed applicant for VISITEC PRECISE-POINT?

The FDA 510(k) record lists Visitec Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VISITEC PRECISE-POINT?

The FDA product code for VISITEC PRECISE-POINT is GAP.

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Other records listing Visitec Co. 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.

K953394VISITEC COLLAR BUTTON CATHETER {GRIFFITHS}K945114VISITEC SCLERAL PLUGK945738VISIFLEX OPHTHALMIC SURGICAL INCISE DRAPEK945172VISITEC SILICONE RETINAL IMPLANTS/EXPLANTSK934269FIBEROPTIC ILLUMINATED INSTRUMENTSK940210VISITEC EYE PAD

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Related Devices (Code: GAP)

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.

K241486Sofsilk™ Coated Braided Silk SutureCovidienK222944SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene SutureSafepath Medical, Inc.K232355Non absorbable Surgical Silk SutureShandong Haidike Medical Product Co., Ltd.K221767Surgical Sutures with or without NeedleHuaian Seamen Medical Technology Co., Ltd.K180701SafePath Suturing SystemSafepath Medical, Inc.K172149FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical SutureM/s. Meril Endo Surgery Private Limited.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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