Atlas FDA

NEEDLES AND SUTURES, SILK & NYLON

FDA 510(k) clearance K760158 · decided 1976-08-19

Clearance details

K-number
K760158
Device name
NEEDLES AND SUTURES, SILK & NYLON
Applicant
Alcon Laboratories
Decision
Substantially Equivalent
Date received
1976-07-02
Decision date
1976-08-19
Days to decision
48 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
Mchenry, IL, US
Third-party review
No
Expedited review
No

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

RecordFirmDate
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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

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
VISCOAT™ Ophthalmic Viscosurgical Device; DUOVISC™ Ophthalmic Viscoelastic System; DISCOVISC™ Ophthalmic Viscosurgical D (P840064/S091)Alcon Laboratories2025-10-03
VISCOAT™ Ophthalmic Viscosurgical Device, DISCOVISC™ Ophthalmic Viscosurgical Device (P840064/S090)Alcon Laboratories2025-07-25
DISCOVISC Ophthalmic Viscosurgical Device (P840064/S088)Alcon Laboratories2025-02-26
VISCOAT™ Ophthalmic Viscosurgical Device, DUOVISC Ophthalmic Viscosurgical System (consists of PROVISC and VISCOAT), DIS (P840064/S086)Alcon Laboratories2024-08-12
PMMA Single-Piece Anterior Chamber IOL (P880087/S033)Alcon Laboratories2024-06-20
PMMA Multiple and Single-Piece Posterior Chamber IOLs (P840060/S051)Alcon Laboratories2024-06-20
PMMA Multiple and Single-Piece Posterior Chamber IOLs (P810032/S071)Alcon Laboratories2024-06-20
VISCOAT™ Ophthalmic Viscosurgical Device, DUOVISC™ Ophthalmic Viscosurgical System, DISCOVISC™ Ophthalmic Viscosurgical (P840064/S085)Alcon Laboratories2024-06-17