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FDA 510(k)

PORTEX RING PESSARY PVC-NON STERILE; PORTEX RING PESSARY POLYTHENE- NON STERILE

K-Number: K012277 · 2002-02-11

ApplicantSims Portex , Ltd.
Decision Date2002-02-11
Product CodeHHW
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

PORTEX RING PESSARY PVC-NON STERILE; PORTEX RING PESSARY POLYTHENE- NON STERILE is the device name listed in this FDA 510(k) record. The listed applicant is Sims Portex , Ltd.. It received FDA 510(k) clearance on 2002-02-11 under 510(k) number K012277. The device is classified under product code HHW. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PORTEX RING PESSARY PVC-NON STERILE; PORTEX RING PESSARY POLYTHENE- NON STERILE?

PORTEX RING PESSARY PVC-NON STERILE; PORTEX RING PESSARY POLYTHENE- NON STERILE is a medical device that received FDA 510(k) clearance on 2002-02-11. The listed applicant is Sims Portex , Ltd.. The 510(k) number is K012277.

When did PORTEX RING PESSARY PVC-NON STERILE; PORTEX RING PESSARY POLYTHENE- NON STERILE receive FDA 510(k) clearance?

PORTEX RING PESSARY PVC-NON STERILE; PORTEX RING PESSARY POLYTHENE- NON STERILE received FDA 510(k) clearance on 2002-02-11, under 510(k) number K012277.

Who is the listed applicant for PORTEX RING PESSARY PVC-NON STERILE; PORTEX RING PESSARY POLYTHENE- NON STERILE?

The FDA 510(k) record lists Sims Portex , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PORTEX RING PESSARY PVC-NON STERILE; PORTEX RING PESSARY POLYTHENE- NON STERILE?

The FDA product code for PORTEX RING PESSARY PVC-NON STERILE; PORTEX RING PESSARY POLYTHENE- NON STERILE is HHW.

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Other records listing Sims Portex , Ltd. 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.

K012068WALLACE OOCYTE RETRIEVAL SETS 16G, WALLACE OOCYTE RETRIEVAL SET 17G, MODELS MEONS 1633S, MEONS 1733SK001555SURESAMPLE-WALLACE ENDOMETRIAL SAMPLER, ENDO 26K000628WALLACE OOCYTE RETRIEVAL SET-16G, MODEL MEONS1633; WALLACE OOCYTE RETRIEVAL SET-17G, MODEL MEONS1733

Related Devices (Code: HHW)

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.

K253698Milex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish Pessaries with Support; Milex™ Cube Pessaries; Milex™ Cube Pessaries with Drainage HolesCooper SurgicalK250438CooperSurgical Milex® PessariesCooperSurgical, Inc.K240798Cntrl+ Bladder Support PessaryCntrl+, Inc.K232677Reia pessaryReia, LLCK232525Yoni.Fit Bladder SupportWatkins-Conti Products, Inc.K233548Uresta®Resilia, Inc.

Official Source

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

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