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FDA 510(k)

SILICONE IMPLANTS

K-Number: K812691 · 1981-11-16

ApplicantSutter Biomedical, Inc.
Decision Date1981-11-16
Product CodeMDM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SILICONE IMPLANTS is the device name listed in this FDA 510(k) record. The listed applicant is Sutter Biomedical, Inc.. It received FDA 510(k) clearance on 1981-11-16 under 510(k) number K812691. 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 SILICONE IMPLANTS?

SILICONE IMPLANTS is a medical device that received FDA 510(k) clearance on 1981-11-16. The listed applicant is Sutter Biomedical, Inc.. The 510(k) number is K812691.

When did SILICONE IMPLANTS receive FDA 510(k) clearance?

SILICONE IMPLANTS received FDA 510(k) clearance on 1981-11-16, under 510(k) number K812691.

Who is the listed applicant for SILICONE IMPLANTS?

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

What is the FDA product code for SILICONE IMPLANTS?

The FDA product code for SILICONE IMPLANTS is MDM.

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Other records listing Sutter Biomedical, 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.

K875249SUTTER PHALANGEAL CAPK870200SUTTER FINGER JOINT PROSTHESISK861983SUTTER LESSER METATARSAL CAPK850274SUTTER CPM 9000 -NONMEASURING EXERCISE EQUIPMENTK830974SUTTER CPM 5000K830649SUTTER CPM 2000

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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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