510(k) Report

510(k) · Cleared

Cleared

Medisiss Reprocessed Non-Electric GI Biopsy Forceps

K042659510(k) TraditionalCleared Feb 14, 2005139-day reviewClass I21 CFR 876.1075

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

Medisiss · NON Forceps, Biopsy, Non-Electric, Reprocessed

Cleared on Feb 14, 2005 as substantially equivalent to K912549 (C.R. Bard, Inc., 1991) and 2 other predicates after a 139-day review. Its family tree reaches back 1 generation to 1990.

Decided
Feb 14, 2005
Review
139 days
Class
Class I
Product code
NON
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K900015 (1990). 3 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1996: 1 other ancestor1991: 1 other ancestorK900015 · Non-Electric Biopsy Forceps · Esco Precision, Inc. · 19901990199520002005
Other ancestors, by generation 1 generation back: 2 other ancestors K900015 · Non-Electric Biopsy Forceps · Esco Precision, Inc. · 19900
  1. Root · 1 generation backK900015 Non-Electric Biopsy ForcepsEsco Precision, Inc. · 1990
  2. This deviceK042659 Medisiss Reprocessed Non-Electric GI Biopsy ForcepsMedisiss · 2005
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K900015Non-Electric Biopsy ForcepsEsco Precision, Inc.1990—
0 (this device)K042659Medisiss Reprocessed Non-Electric GI Biopsy ForcepsMedisiss2005—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
199610
FIG. 1 — Lineage of K042659, 1990–2005Source: 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 NON? 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? (3)

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
*K912549Bard (R) Disposable Biopsy Forceps
Summary page 1
…rer's 510(k)s: Manufacturer 510(k)# Bard K9 12549 Esco Precision, Inc. K9000 15 Olympus…
C.R. Bard, Inc.1991—
*K900015Non-Electric Biopsy Forceps
Summary page 1
…510(k)# Bard K9 12549 Esco Precision, Inc. K9000 15 Olympus K(955065 Summary of Validation Data: MediSISS has vali…
Esco Precision, Inc.1990—
*K955065Olympus FB Series Biopsy Forceps
Summary page 1
…K9 12549 Esco Precision, Inc. K9000 15 Olympus K(955065 Summary of Validation Data: MediSISS has validated its cleaning, sterilization, fuinctional performance and packaging and distr…
Olympus America, Inc.1996—

What descends from it?

No later submission names this one as a predicate yet.

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?

  • None of the 3 ancestors has a recall.

How does its category compare?

All NON devices

NON Forceps, Biopsy, Non-Electric, Reprocessed: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NON

FDA has decided no NON device since 2007.

Median 510(k) review, days · NON

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

Recalls per year · NON

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NON

1in 2025

2010: 22012: 92015: 12016: 272017: 62018: 12025: 1
2007high 27 (2016) · low 0 (2007)2025

MAUDE reports naming product code NON, 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—10
20090—00
20100—02
20110—00
20120—09
20130—00
20140—00
20150—01
20160—027
20170—06
20180—01
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—01
20260—0—

What is it indicated for?

The MediSISS Reprocessed Non-electric Biopsy Forceps are intended to be used to remove polyps, and obtain a specimen of tissue for microscopic examination.

Indications for use as stated in the FDA summary.

More from Medisiss

6 FDA decisions under this applicant name. See the company

  • K113028Medisiss Reprocessed Arthroscopic Shavers and BursMedisiss · 2011
  • K100543Medississ Reprocessedent Ablation Wands (Coblators), Model#EIC8872-01Medisiss · 20101 recall
  • K081559GenesisMedisiss · 2008
  • K030598Medisiss Reprocessed Ultrasonic Surgical InstrumentsMedisiss · 2004
  • K030919Siss, Inc. (D.B.a.Medisiss) Reprocessd Electrosurgical Instruments and AccessoriesMedisiss · 2003

Recent decisions in NON

The NON category page

  • K042648Reprocessed Cold Biopsy ForcepsSterilmed, Inc. · 20051 recall
  • K042594Vanguard Reprocessed Non-Electric Biopsy ForcepsVanguard Medical Concepts, Inc. · 2005

https://510kreport.com/device/K042659 · printed Nov 6, 2026

Cite this page

510(k) Report. “K042659: Medisiss Reprocessed Non-Electric GI Biopsy Forceps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042659

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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