510(k) Report

510(k) · Cleared

Cleared

Titanium Hemostatic Clip

K972745510(k) TraditionalCleared Oct 21, 199790-day reviewClass II21 CFR 878.4300

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Eisner USA, Inc. · MCH Clip, Hemostatic

Cleared on Oct 21, 1997 as substantially equivalent to K953258 (Intramed Laboratories, Inc., 1996) and 3 other predicates after a 90-day review. Its family tree reaches back 1 generation to 1977. 4 later devices descend from it.

Decided
Oct 21, 1997
Review
90 days
Class
Class II
Product code
MCH
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to K771021 (1977). 4 ancestors in all. 4 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1996: 1 other ancestor1985: 1 other ancestor1980: 1 other ancestor1998: 1 descendant cleared2004: 1 descendant cleared2025: 1 descendant cleared2019: 1 descendant clearedK771021 · Auto-Clip · Axiom Medical, Inc. · 197719801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 1 descendant2 generations forward: 3 descendants K771021 · Auto-Clip · Axiom Medical, Inc. · 19770
  1. Root · 1 generation backK771021 Auto-ClipAxiom Medical, Inc. · 1977
  2. This deviceK972745 Titanium Hemostatic ClipEisner USA, Inc. · 1997
  3. Descendant · cites it directly · 3 of its ownK981645 Titanium Hemostatic ClipVitalitec Int'L., Inc. · 1998
  4. Descendant · 2 generations on · 0 of its ownK242541 Gem ZipclipSynovis Micro Companies Alliance A Subsidiary of Baxter Int · 2025
  5. Descendant · 2 generations on · 0 of its ownK192711 Dannik Titanium Ligation ClipDannik · 2019
  6. Descendant · 2 generations on · 0 of its ownK040602 Sureline Laparoscopic Clip Applier with Implantable Titanium ClipsDesign Standards Corp. · 2004

Most influential descendants

Showing 4 of 4 · See all
  • K981645Titanium Hemostatic ClipVitalitec Int'L., Inc. · 1998 · cites it directly3descendants
  • K242541Gem ZipclipSynovis Micro Companies Alliance A Subsidiary of Baxter Int · 2025 · 2 generations on0descendants
  • K192711Dannik Titanium Ligation ClipDannik · 2019 · 2 generations on0descendants
  • K040602Sureline Laparoscopic Clip Applier with Implantable Titanium ClipsDesign Standards Corp. · 2004 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K771021Auto-ClipAxiom Medical, Inc.1977—
0 (this device)K972745Titanium Hemostatic ClipEisner USA, Inc.1997—
+1K981645Titanium Hemostatic ClipVitalitec Int'L., Inc.1998—
+2K242541Gem ZipclipSynovis Micro Companies Alliance A Subsidiary of Baxter Int2025—
+2K192711Dannik Titanium Ligation ClipDannik2019—
+2K040602Sureline Laparoscopic Clip Applier with Implantable Titanium ClipsDesign Standards Corp.2004—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198010
198510
199610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
200410
201910
202510
FIG. 1 — Lineage of K972745, 1977–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MCH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (5)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K953258Titanium Hemostatic Clip
Summary page 1
…ing and Materials (ASTM) standard specification F-67 95 “Unalloyed Titanium for Surgical Implant Applications”, Grade L. Predicate Devices: Baxter Healthcare Vitaclip® K953258, Edward Weck & Company, Pre- amendment Hemoclip® Surgical Occluding System and Hemoclip® Surgical Occluding Clip Stainless Steel…
Intramed Laboratories, Inc.1996—
*K800079Hemoclip Surgical Occluding Clip
Summary page 1
…ces: Baxter Healthcare Vitaclip® K953258, Edward Weck & Company, Pre- amendment Hemoclip® Surgical Occluding System and Hemoclip® Surgical Occluding Clip Stainless Steel K800079, United States Surgical Corporation, Auto Suture® Titanium Hemostatic Clip K853650 and Axiom Auto-Clip® K771021. Comparison of T…
Edward Weck, Inc.19801
*K853650Auto Suture Titanium Hemostatic Clip
Summary page 1
…oclip® Surgical Occluding System and Hemoclip® Surgical Occluding Clip Stainless Steel K800079, United States Surgical Corporation, Auto Suture® Titanium Hemostatic Clip K853650 and Axiom Auto-Clip® K771021. Comparison of Technological Characteristics: The titanium clip material is identical to the predic…
United States Surgical, A Division of Tyco Healthc1985—
*K771021Auto-Clip
Summary page 1
…tem and Hemoclip® Surgical Occluding Clip Stainless Steel K800079, United States Surgical Corporation, Auto Suture® Titanium Hemostatic Clip K853650 and Axiom Auto-Clip® K771021. Comparison of Technological Characteristics: The titanium clip material is identical to the predicate devices. In function, the…
Axiom Medical, Inc.1977—
*—Edward Weck & Company, Pre-amendment Hemoclip® Surgical Occluding System
Named without a submission number
—

Also cleared against K953258: 1 other device →

What descends from it? (4)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K981645Titanium Hemostatic ClipVitalitec Int'L., Inc.19983

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • 1 of the 4 ancestors has a recall of any class.
  • Of its descendants, K981645 (Vitalitec Int'L., Inc., 1998) has gone furthest, with 3 descendants of its own.
  • 1 other device also cites its predicate K953258.

How does its category compare?

All MCH devices

MCH Clip, Hemostatic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MCH

FDA has decided no MCH device since 2007.

Median 510(k) review, days · MCH

Too few MCH 510(k)s in any year since 2007 to give a median.

Recalls per year · MCH

No recall names MCH since 2007.

Adverse event reports per year · MCH

1in 2023

2008: 12009: 12014: 472015: 412017: 12018: 922019: 772020: 532021: 272022: 1252023: 1
2007high 125 (2022) · low 0 (2007)2025

MAUDE reports naming product code MCH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—01
20090—01
20100—00
20110—00
20120—00
20130—00
20140—047
20150—041
20160—00
20170—01
20180—092
20190—077
20200—053
20210—027
20220—0125
20230—01
20240—00
20250—00
20260—0—

What is it indicated for?

The EISNER USA Hemostatic Clip is designed for the intended use of ligating blood vessels. The clip has been specially designed to insure occlusion of vessels and prevent any slippage once applied. The clip has applications in many types of surgical procedures where hemostasis is required or radiographic marking is necessary. As the clip is made of Commercially Pure - GRADE I, Implant Titanium (ASTM Standard F-67 95), it has low magnetic susceptibility…

Read the full statement (186 words)

The EISNER USA Hemostatic Clip is designed for the intended use of ligating blood vessels. The clip has been specially designed to insure occlusion of vessels and prevent any slippage once applied. The clip has applications in many types of surgical procedures where hemostasis is required or radiographic marking is necessary.

As the clip is made of Commercially Pure - GRADE I, Implant Titanium (ASTM Standard F-67 95), it has low magnetic susceptibility and is safe for use in the present clinical MRI environment with main Magnetic fields up to 2 Telsa and maximum main field-gradients up to 500 gauss per centimeter. The Magnetic Force will only approach gravitational force for MR Systems above 15 T.

As the clip is made of Commercially Pure - GRADE I, Implant Titanium (ASTM Standard F-67-95), it also produces less artifact and better resolution of anatomic structures than non-titanium clips in CT Scanning.

(Choose the size of clip to fit the procedure making certain the tissue to be occluded fits completely within the clip. The EISNER USA Clip can be left in vivo without sequela as it is biologically inert.)

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K953258

1 other device cites the same predicate.

  • K981645Titanium Hemostatic ClipVitalitec Int'L., Inc. · 1998

Recent decisions in MCH

The MCH category page

  • K040148Resolution Hemostasis Clipping DeviceBoston Scientific Corp · 20042 recalls
  • K896998Atrauclip (Tantalum Hemostatic Clip)S.P.K. Technology, Inc. · 1990

https://510kreport.com/device/K972745 · printed Nov 4, 2026

Cite this page

510(k) Report. “K972745: Titanium Hemostatic Clip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972745

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026