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FDA 510(k)

MENTOR RAPID-SPAN (TM) TISSUE EXPANDER

K-Number: K883303 · 1988-08-26

ApplicantMentor Corp.
Decision Date1988-08-26
Product CodeFZW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MENTOR RAPID-SPAN (TM) TISSUE EXPANDER is the device name listed in this FDA 510(k) record. The listed applicant is Mentor Corp.. It received FDA 510(k) clearance on 1988-08-26 under 510(k) number K883303. The device is classified under product code FZW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MENTOR RAPID-SPAN (TM) TISSUE EXPANDER?

MENTOR RAPID-SPAN (TM) TISSUE EXPANDER is a medical device that received FDA 510(k) clearance on 1988-08-26. The listed applicant is Mentor Corp.. The 510(k) number is K883303.

When did MENTOR RAPID-SPAN (TM) TISSUE EXPANDER receive FDA 510(k) clearance?

MENTOR RAPID-SPAN (TM) TISSUE EXPANDER received FDA 510(k) clearance on 1988-08-26, under 510(k) number K883303.

Who is the listed applicant for MENTOR RAPID-SPAN (TM) TISSUE EXPANDER?

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

What is the FDA product code for MENTOR RAPID-SPAN (TM) TISSUE EXPANDER?

The FDA product code for MENTOR RAPID-SPAN (TM) TISSUE EXPANDER is FZW.

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Other records listing Mentor 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.

K130813MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TISSUE EXPANDERSK053414MENTOR NOVASILK MESHK050008MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETERK042851MENTOR OBTAPE TRANS-OBTURATOR SURGICAL KITK040959MENTOR GENESIS PENILE PROSTHESISK031767MENTOR OBTAPE TRANS-OBTURATOR TAPE

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Related Devices (Code: FZW)

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.

K080158LB MEDICAL INFLATABLE TISSUE ELEVATOR/EXPANDER SYSTEMLb Medical LLCK984448BIRCOLL BALLOON DISSECTORWells Johnson Co.K972109SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDERGeneral Surgical InnovationsK936186AESCULAP SKIN GRAFT MESHERAesculap, Inc.K904265INAMED RUIZ-COHEN INTRAOPERATIVE TISSUE EXPANDERInamed Development Co.K902349SURGITEK INTRA-SPAN INTRAOPERATIVE TISSUE EXPANDERSurgitek

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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