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FDA 510(k)

MONOPLUS POLY-P-DIOXANONE MONOFILAMENT ABSORBABLE SURGICAL SUTURE

K-Number: K031216 · 2003-07-17

ApplicantAesculap
Decision Date2003-07-17
Product CodeNEW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MONOPLUS POLY-P-DIOXANONE MONOFILAMENT ABSORBABLE SURGICAL SUTURE is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap. It received FDA 510(k) clearance on 2003-07-17 under 510(k) number K031216. The device is classified under product code NEW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MONOPLUS POLY-P-DIOXANONE MONOFILAMENT ABSORBABLE SURGICAL SUTURE?

MONOPLUS POLY-P-DIOXANONE MONOFILAMENT ABSORBABLE SURGICAL SUTURE is a medical device that received FDA 510(k) clearance on 2003-07-17. The listed applicant is Aesculap. The 510(k) number is K031216.

When did MONOPLUS POLY-P-DIOXANONE MONOFILAMENT ABSORBABLE SURGICAL SUTURE receive FDA 510(k) clearance?

MONOPLUS POLY-P-DIOXANONE MONOFILAMENT ABSORBABLE SURGICAL SUTURE received FDA 510(k) clearance on 2003-07-17, under 510(k) number K031216.

Who is the listed applicant for MONOPLUS POLY-P-DIOXANONE MONOFILAMENT ABSORBABLE SURGICAL SUTURE?

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

What is the FDA product code for MONOPLUS POLY-P-DIOXANONE MONOFILAMENT ABSORBABLE SURGICAL SUTURE?

The FDA product code for MONOPLUS POLY-P-DIOXANONE MONOFILAMENT ABSORBABLE SURGICAL SUTURE is NEW.

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Other records listing Aesculap 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.

K093649AESCULAP STERILCONTAINER SK062085S4 SPINAL SYSTEMK062510AESCULAP STERILCONTAINER SYSTEMK061135MINOP DISPOSABLE INTRODUCER 10F, MODEL ME010; 19F, MODEL ME019K043079BICONTACT HIP SYSTEM WITH U-CAPK040865AESCULAP STERRAD 100S COMPATABLE STERILCONTAINER

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Related Devices (Code: NEW)

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.

K254238MINT MONO SuturesHans Biomed CorporationK253879MONOFIX PDOSamyang Holdings CorporationK261988Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical SutureTeleflex Medical, LLCK252171Barbed PDO SutureSutura Medical Technology, Inc.K252047STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control DevicesETHICON, Inc.K243897PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical SutureETHICON, 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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