Atlas FDA

AUTOMATIC MULTICLIP DISPOS. LIGATING

FDA 510(k) clearance K843336 · decided 1984-10-31

Clearance details

K-number
K843336
Device name
AUTOMATIC MULTICLIP DISPOS. LIGATING
Applicant
Davis & Geck, Inc.
Decision
Substantially Equivalent
Date received
1984-08-27
Decision date
1984-10-31
Days to decision
65 days
Clearance type
Traditional
Product code
FZP
Device class
2
Regulation number
878.4300
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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Similar devices under this product code

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

RecordFirmDate
Inno-Hook™ Disposable Clip Appliers (Ligating Clips) and Inno-Hook™ Ligating Clips (K254231)Taiwan Surgical Corporation2026-07-20
InnoClip Disposable Clip Applier (K253903)Taiwan Surgical Corporation2025-12-22
InnoClip Clip Applier (K253781)Taiwan Surgical Corporation2025-12-22
Disposable Polymer Ligation Clips (K250643)Hangzhou Kangji Medical Instrument Co., Ltd.2025-11-20
Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips (K251054)Teleflex Medical2025-07-03
GEM ZIPCLIP (K242541)Synovis Micro Companies Alliance A Subsidiary of Baxter Int2025-01-15
SOLID CLIP™ Single Use Clip Applier (K221495)Medscope Biotech Co., Ltd.2024-07-18
Hem-o-lok® Ligating Clips (K232970)Teleflex Medical2024-01-12
angiOCCLUDE Ligating Clips (K230966)A2 Medical Systems, LLC2023-09-19
LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic Rotating Multiple Clip Applier 10mm M/L (ER320) (K232313)Ethicon Endo Surgery, LLC2023-08-29
Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML) (K230480)Teleflex Medical2023-04-28
DuraFuse Clip and Applier System (K213813)Neuramedica, Inc.2022-07-22

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