Atlas FDA

ETHIBOND*

FDA premarket approval N17809/S002 · decided 1981-07-07

Approval details

PMA number
N17809
Supplement
S002
Trade name
ETHIBOND*
Generic name
Suture, nonabsorbable, synthetic, polyester
Applicant
ETHICON, Inc.
Date received
1980-12-04
Decision date
1981-07-07
Days to decision
215 days
Decision code
APPR
Product code
GAS
Advisory committee
General, Plastic Surgery
Expedited review
No
Location
Somerville, NJ

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510(k) clearances by this applicant

RecordFirmDate
Coated VICRYL™ (Polyglactin 910) Plus Antibacterial Suture (K253394)ETHICON, Inc.2026-06-25
STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices (K252047)ETHICON, Inc.2026-05-18
STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control Device (K253572)ETHICON, Inc.2026-03-27
MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture (K253852)ETHICON, Inc.2026-02-06
STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device (K252743)ETHICON, Inc.2025-12-22
PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture (K243897)ETHICON, Inc.2025-11-12
STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device (K221744)ETHICON, Inc.2022-11-15
PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture (K212380)ETHICON, Inc.2022-02-22