MICROSURGE LAPAROSCOPIC PERMACLIP CARTRIDGE WITH IMPLANTABLE CLIP
K964109 · Microsurge, Inc. · FZP · Nov 27, 1996 · General, Plastic Surgery
Device Facts
| Record ID | K964109 |
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| Device Name | MICROSURGE LAPAROSCOPIC PERMACLIP CARTRIDGE WITH IMPLANTABLE CLIP |
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| Applicant | Microsurge, Inc. |
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| Product Code | FZP · General, Plastic Surgery |
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| Decision Date | Nov 27, 1996 |
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| Decision | SESE |
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| Submission Type | Traditional |
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| Regulation | 21 CFR 878.4300 |
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| Device Class | Class 2 |
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| Attributes | Therapeutic |
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Intended Use
The PermaClip™ Cartridge with implantable titanium clips is intended for use during laparoscopic surgery to occlude a variety of vessels or other tubular structures.
Device Story
Disposable laparoscopic clip cartridge; contains up to 12 titanium clips; used with reusable PermaClip™ Multi-Use Clip Applier. Inserted through 10 mm trocar; jaws placed around vessel/tubular structure; handle actuation closes jaws to form clip; release mechanism feeds next clip. Used by surgeons in laparoscopic procedures to achieve hemostasis or structure occlusion. Benefits include secure vessel ligation via minimally invasive access.
Clinical Evidence
No clinical data; bench testing only.
Technological Characteristics
Materials: biocompatible stainless steel, medical grade polymers, titanium clips. Form factor: cartridge sized for 10 mm cannula, 33 mm shaft length. Mechanism: mechanical jaw actuation and automatic clip feeding. Sterilization: not specified.
Indications for Use
Indicated for use in laparoscopic surgery to occlude blood vessels and other tubular structures in patients requiring such procedures.
Regulatory Classification
Identification
An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.
Predicate Devices
- United States Surgical Corporation
- Ethicon Endosurgery
- Pilling Weck
Related Devices
- K040602 — SURELINE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS · Design Standards Corp. · May 10, 2004
- K993135 — IMPLANTABLE CLIP FOR GENERAL SURGERY · Applied Medical Resources · Dec 1, 1999
- K253781 — InnoClip Clip Applier · Taiwan Surgical Corporation · Dec 22, 2025
- K013695 — MICROLINE INC. REUSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS, MODEL M/L-10 · Microline Pentax, Inc. · Jan 8, 2002
- K981239 — DEROYAL INDUSTRIES DISPOSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS · Deroyal Surgical · May 14, 1998
Submission Summary (Full Text)
{0}
Microsurge Permaclip
510(k) October 11, 1996
K964109
NOV 27 1996
# 510 (k) SUMMARY: Microsurge Laparoscopic PermaClip™ Cartridge with Implantable Titanium Clips
(1) Microsurge, Inc.
150 A Street
Needham, MA 02194
(617) 444-2300
Contact Person: Richard Lariviere
Date Summary Prepared: Oct. 11, 1996
(2) Trade or Proprietary Name: Microsurge Laparoscopic PermaClip™ Cartridge with Implantable Titanium Clips
Common Name: Laparoscopic Clip Cartridge with Implantable Titanium Clips
Classified Name: Implantable Clip (74FZP), 21 CFR 878.4300, Class II
(3) Predicates: United States Surgical Corporation
Ethicon Endosurgery
Pilling Weck
(4) Description of Device:
The Microsurge Laparoscopic PermaClip™ Cartridge with implantable titanium clips is a disposable single patient use device fabricated from biocompatible stainless steels and biocompatible medical grade polymers. The PermaClip™ cartridge contains up to 12 implantable titanium clips. The closed clip length is approximately 9 mm. The device is designed to be used in conjunction with a separately supplied
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{1}
Microsurge Permaclip
510(k) October 11, 1996
reusable PermaClip™ Multi-Use Clip Applier to occlude blood vessels and other tubular structures during laparoscopic surgical procedures. The clip cartridge is attached to the clip applier handle via a lock/release mechanism, and inserted through a trocar to gain laparoscopic access. The clip cartridge jaws with the open clip in the jaws is placed around the vessel or other tubular structure. Actuation/compression of the clip applier handle/trigger drives a mechanism within the cartridge to close the cartridge jaws, thereby forming the clip securely around the vessel. Release/decompression of the clip applier handle/trigger allows the jaws of the cartridge to open and releases the clip from the cartridge jaws. The automatic feeding cartridge releases the next clip into the jaws for another application.
The cartridge is sized to fit through a 10 mm cannula. The overall shaft length of the cartridge plus the clip applier handle is approximately 33 mm, consistent with other endoscopic instruments.
(5) Intended Use:
The PermaClip™ Cartridge with implantable titanium clips is intended for use during laparoscopic surgery to occlude a variety of vessels or other tubular structures.
(6) Technological Characteristics:
The PermaClip™ Cartridge with implantable titanium clips has similar/same technological characteristics as the predicate devices in that they are comprised of similar design, materials, and are intended for use to clip vessels or tubular structures during laparoscopic surgery.
(7) Conclusion:
The new device has the same intended use and the same basic technology as the predicates identified in the premarket notification submission. The new device contains in some combination similar/same features, materials, and design as the predicates and does not pose any new questions concerning safety and effectiveness.
