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FDA 510(k)

CUTO(TM) TISSUE MORCELLATION SYSTEM

K-Number: K932700 · 1993-10-15

ApplicantLinvatec Corp.
Decision Date1993-10-15
Product CodeGEY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CUTO(TM) TISSUE MORCELLATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Linvatec Corp.. It received FDA 510(k) clearance on 1993-10-15 under 510(k) number K932700. The device is classified under product code GEY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CUTO(TM) TISSUE MORCELLATION SYSTEM?

CUTO(TM) TISSUE MORCELLATION SYSTEM is a medical device that received FDA 510(k) clearance on 1993-10-15. The listed applicant is Linvatec Corp.. The 510(k) number is K932700.

When did CUTO(TM) TISSUE MORCELLATION SYSTEM receive FDA 510(k) clearance?

CUTO(TM) TISSUE MORCELLATION SYSTEM received FDA 510(k) clearance on 1993-10-15, under 510(k) number K932700.

Who is the listed applicant for CUTO(TM) TISSUE MORCELLATION SYSTEM?

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

What is the FDA product code for CUTO(TM) TISSUE MORCELLATION SYSTEM?

The FDA product code for CUTO(TM) TISSUE MORCELLATION SYSTEM is GEY.

Related Clinical Trials

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.

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Other records listing Linvatec Corp. 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.

K092998CONMED LINVATEC INTERCEPT IMPLANTK091549CONMED LINVATEC SOFT TISSUE TO BONE SYSTEMK090835CONMED LINVATEC BIO MINI-REVO SUTURE ANCHOR, MODEL C6170CRK090186CONMED LINVATEC PALADIN, PRELOADED WITH TWO #2 HI-FI SUTURESK083281EL LIGHTWAVE SUCTION ABLATOR, MODEL EL-2000-S, LIGHTWAVE SUCTION ABLATOR, MODEL IA-2000-S, LIGHTWAVE ABLATOR, MODEL IA-K060198MICROPOWER HAND PIECE : MEDIUM SPEED DRILL, SAGGITAL SAW, RECIPROCATING SAW, AND OSCILLATING SAW

View all 93 devices →

Related Devices (Code: GEY)

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.

K050519ADVANCED TURBO DRIVE SYSTEMLinvatec Corp.K020621ARTHROCARE CONTROLLER; ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; WANDSArthrocare Corp.K012738SYMPHONY GRAFT DELIVERY SYSTEM (GDS)DepuyacromedK972308MEDNEXT 1000 DRILLMednext, Inc.K971941AQUA SPRAYBoyd Industries, Inc.K971782BONE AND MARROW COLLECTION SYSTEM KITBiomedical Ent., Inc.

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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