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SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene Suture

FDA 510(k) clearance K222944 · decided 2024-10-18

Clearance details

K-number
K222944
Device name
SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene Suture
Applicant
Safepath Medical, Inc.
Decision
Substantially Equivalent
Date received
2022-09-26
Decision date
2024-10-18
Days to decision
753 days
Clearance type
Traditional
Product code
GAP
Device class
2
Regulation number
878.5030
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Amesbury, MA, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Sofsilk™ Coated Braided Silk Suture (K241486)Covidien2024-12-03
Non absorbable Surgical Silk Suture (K232355)Shandong Haidike Medical Product Co., Ltd.2024-01-16
Surgical Sutures with or without Needle (K221767)Huaian Seamen Medical Technology Co., Ltd.2023-07-31
SafePath Suturing System (K180701)Safepath Medical, Inc.2018-06-25
FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture (K172149)M/s. Meril Endo Surgery Private Limited.2017-10-20
SILK Surgical Suture (K162396)Teleflexmedical, Inc.2016-11-23
FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture (K160623)M/s. Meril Endo Surgery Private Limited.2016-05-31
WG-SURGICAL SUTURES WITH NEEDLE (K080684)Foosin Medical Supplies, Inc.2008-06-09
NON-ABSORBABLE SILK SUTURE (K071111)Arrow Intl., Inc.2007-07-17
MANI NEEDLE & SUTURE PACK (SILK) (K053638)Mani, Inc.2006-05-19
TRUESILK NON-ABSORBABLE SILK SURGICAL SUTURE (K041514)Sutures India Private Limited2005-06-03
UNISILK (K042282)United Medical Industries Co. , Ltd.2004-12-01

Recalls involving this device

No recalls on record reference this clearance.