Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9680770

FEI Number

3006795395

Entity Name

TREWAVIS SURGICAL INSTRUMENTS PTY LTD.

City/State/Country

Bayswater Victoria, AU

Establishment Address

21 Michellan Court, Bayswater Victoria 3153, AU

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

TREWAVIS SURGICAL INSTRUMENTS PTY LTD (Owner Number: 9011291)

Owner / Operator Contact Address

21 Michellan Court, Bayswater, AU-VIC 3153, AU

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K902097

PMA Number

N/A

All Registered Proprietary Names

Trewavis Surgical JC Medical

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FCK	Instrument, Biopsy, Suction	Gastroenterology, Urology	Class 2	876.1075	2007-11-20

Official Correspondent

GENE THALAPPILLIL

US Agent Details

Ann Laird Business: NORTHSTAR SURGICAL, INC. Email: alaird@northstarsurgical.com Phone: (952) 9281490

Related Public Records

Same Entity

TREWAVIS SURGICAL INSTRUMENTS PTY LTD

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9680770. Last updated year: 2026. Please use registration number 9680770 when referencing this establishment in official correspondence.