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FDA 510(k)

SAPHLIFT

K-Number: K990062 · 1999-03-30

ApplicantGenzyme Surgical Product (Genzyme Biosurgery)
Decision Date1999-03-30
Product CodeMDM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SAPHLIFT is the device name listed in this FDA 510(k) record. The listed applicant is Genzyme Surgical Product (Genzyme Biosurgery). It received FDA 510(k) clearance on 1999-03-30 under 510(k) number K990062. The device is classified under product code MDM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAPHLIFT?

SAPHLIFT is a medical device that received FDA 510(k) clearance on 1999-03-30. The listed applicant is Genzyme Surgical Product (Genzyme Biosurgery). The 510(k) number is K990062.

When did SAPHLIFT receive FDA 510(k) clearance?

SAPHLIFT received FDA 510(k) clearance on 1999-03-30, under 510(k) number K990062.

Who is the listed applicant for SAPHLIFT?

The FDA 510(k) record lists Genzyme Surgical Product (Genzyme Biosurgery) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SAPHLIFT?

The FDA product code for SAPHLIFT is MDM.

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Other records listing Genzyme Surgical Product (Genzyme Biosurgery) 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.

K001440NEXTSTITCH CARDIOVASCULAR VALVE SUTUREK001434'COTTONY' II DACRON, SILKY II POLYDEK & TEVDEK II POLYESTER NONABSORBABLE SURGICAL SUTUREK992088BONDEK PLUS POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTUREK991416ENDOSCOPIC CAMERAK991191BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTUREK982712RAPID TRANSFER BLOOD BAG MODEL A-1650, RAPID TRANSFER BLOOD BAG MODEL S-250

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Related Devices (Code: MDM)

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.

K073664FRONTLINE MEDICAL SAFETYNET GUIDEWIRE INTRODUCERInjectimed, Inc.K050575FUTUMEDS NO PATIENT CONTACT SAFETY LANCET WITH PALS SYSTEMFutumeds Sdn BhdK050957EUTROCHARSpecial Devices, Inc.K023173ANDREWS INTRODUCER, MODEL ASI01Andrews Surgical Innovations, Ltd.K022059MICROVASIVE PULMONARY GUIDEWIREBoston Scientific CorpK013040LIGHT SABER INTRODUCER NEEDLEMinrad, 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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