Atlas FDA

STAINLESS STEEL SUTURES, FLEXON STEEL SUTURES (STAINLESS)

FDA 510(k) clearance K955723 · decided 1996-02-27

Clearance details

K-number
K955723
Device name
STAINLESS STEEL SUTURES, FLEXON STEEL SUTURES (STAINLESS)
Applicant
Davis & Geck, Inc.
Decision
Substantially Equivalent for Some Indications
Date received
1995-12-18
Decision date
1996-02-27
Days to decision
71 days
Clearance type
Traditional
Product code
GAQ
Device class
2
Regulation number
878.4495
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Danbury, CT, US
Third-party review
No
Expedited review
No

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RecordFirmDate
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FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES (USP) 5-0 TO #5 (K081060)Core Essence Orthopaedics, LLC2008-12-24
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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
MAXON AND MAXON CV POLYGLYCONATE MONOFILAMENT ABSORBABLE SURGICAL SUTURE (P840051/S008)Davis & Geck, Inc.1996-11-15
MAXON AND MAXON CV POLYGLYCONATE MONOFILAMENT ABSORBABLE SURGICAL SUTURE (P840051/S007)Davis & Geck, Inc.1996-01-11
NOVAFIL(R) AND VASCUFIL(R) POLYBUTESTER MONOFILAMENT NONABSORBABLE SURGICAL SUTURE (P840041/S006)Davis & Geck, Inc.1996-01-11
NOVAFIL(TM) (P840041/S005)Davis & Geck, Inc.1994-04-20
MAXON(TM) POLYGLYCONATE MONOFILAMENT ABSORBABLE SU (P840051/S006)Davis & Geck, Inc.1992-03-24
MAXON(TM) POLYGLYCONATE MONOFILAMENT ABSORBABLE SU (P840051/S005)Davis & Geck, Inc.1991-10-17
MAXON(TM) POLYGLYCONATE MONOFILAMENT ABSORBABLE SU (P840051/S004)Davis & Geck, Inc.1991-03-29
NOVAFIL(TM) (P840041/S003)Davis & Geck, Inc.1990-07-06