Atlas FDA

APPOSE ULTRA DISPOS. SKIN STAPLER W/AUTO RELEASE

FDA 510(k) clearance K844417 · decided 1984-12-17

Clearance details

K-number
K844417
Device name
APPOSE ULTRA DISPOS. SKIN STAPLER W/AUTO RELEASE
Applicant
Davis & Geck, Inc.
Decision
Substantially Equivalent
Date received
1984-11-15
Decision date
1984-12-17
Days to decision
32 days
Clearance type
Traditional
Product code
GAG
Device class
2
Regulation number
878.4740
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Danbury, CT, 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
Tri-Staple™ 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple™ 2.0 Black Circular Reload 25mm Extra Thick (SIGCIR25XT) (K253527)Covidien, LLC2026-07-01
AEON™ Endoscopic Powered Stapler (K251482)Lexington Medical, Inc.2025-07-11
da Vinci SP SureForm 45 Staplers and Reloads (SP1098) (K243596)Intuitive Surgical, Inc.2025-03-10
Signia™ Circular Adapter (Standard Length) (SIGCIRSTND); Signia™ Circular Adapter XL Length (SIGCIRXL) (K240881)Covidien (Part of Medtronic)2024-11-01
ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S); Echelon 3000 45mm Long Stapler (ECH45L); Echelon 3000 60mm Compact Stapler (ECH60C); Echelon 3000 60mm Standard Stapler (ECH60S); Echelon 3000 60mm Long Stapler (ECH60L) (K241629)Ethicon Endo-Surgery, LLC2024-07-03
AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler (Medium/AEPH160); AEON Endoscopic Powered Stapler (Long/AEPH260) (K234039)Lexington Medical, Inc.2024-05-07
GIA™ Stapler with Tri-Staple™ Technology (K231934)Covidien2023-10-27
TA™ Stapler and Loading Unit with DST Series™ Technology (K231491)Covidien2023-08-16
EEA™Circular Stapler with Tri-Staple™ Technology and OrVil™ Transoral Circular Stapler Anvil (K232126)Covidien2023-08-16
Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Circular Adapters) (K221629)Covidien2023-02-22
ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler (K213633)Ethicon Endo-Surgery, LLC2022-04-08
PROXIMATE DISPOSABLE SKIN STAPLER (K970079)Ethicon Endo-Surgery, Inc.1997-03-11

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