Cleared Traditional

K132958 - MEDICINAL LEECHES

K132958 · North America BioPharma · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2014
Decision
152d
Days
-
Risk

K132958 is an FDA 510(k) clearance for the MEDICINAL LEECHES. Classified as Leeches, Medicinal (product code NRN).

Submitted by North America BioPharma (Erie, US). The FDA issued a Cleared decision on February 19, 2014 after a review of 152 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K132958

510(k) Number K132958 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2013
Decision Date February 19, 2014
Days to Decision 152 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d slower than avg
Panel avg: 115d · This submission: 152d
Pathway characteristics
Predicate-based equivalence.

NRN Device Classification - Class 0,

Product Code NRN Leeches, Medicinal
Device Class -
Definition The Device Is A Medicinal Leech (hirudo Medicinalis) Belonging To The Annelida Worm Classification. The Animal Is A Bloodsucking Aquatic Animal Living In Fresh Water. The Device Should Be Indicated As: "an Adjunct To The Graft Tissue Healing When Problems Of Venous Congestion May Delay Healing, Or To Overcome The Problem Of Venous Congestion By Creating Prolonged Localized Bleeding." See Federal Register Notice At 89 Fr 106521 “transfer Of Regulatory Responsibility From The Center For Devices And Radiological Health To The Center For Biologics Evaluation And Research; Medical Maggots And Medicinal Leeches” (frn) (fda-2024-n-5702)

Regulatory Consultant

Biopharm (Uk) , Ltd.
Bethany Sawyer

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

K132958 · MEDICINAL LEECHES
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