Data / Medical devices / United States / Modern Surgical Instruments LLC

Modern Surgical Instruments LLC: FDA-registered device maker in Westerville, OH, United States, 2 510(k) clearances

Name: Modern Surgical Instruments LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Modern Surgical Instruments LLC is registered with the FDA (registration 3009822485) in Westerville, OH, United States. It lists 20 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 8, 2019. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3009822485
Address: 6295 Maxtown RD Ste 700, Westerville, OH, United States, 43082
Owner or operator: Modern Surgical Instruments LLC (10048427)
Roles: Complaint file establishment, Repackager or relabeler
First device listed: January 12, 2015
Registered through: 2026
Brand names listed: BB, Curette, Dissector, Elevator, Forceps, Frazier Suction Tip, Teardrop Type, 6FR, Natural Color, Sterile, Gauge, Impactor and more

Devices it lists

Device	Product code	Class	Role	Source
Catheter And Tip, Suction	JOL	2	Repackager or relabeler	accessdata.fda.gov
Curette, Surgical, General Use	FZS	1	Repackager or relabeler	accessdata.fda.gov
Dissector, Surgical, General & Plastic Surgery	GDI	1	Repackager or relabeler	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Elevator, Surgical, General & Plastic Surgery	GEG	1	Repackager or relabeler	accessdata.fda.gov
Forceps, Ent	KAE	1	Repackager or relabeler	accessdata.fda.gov
Forceps, General & Plastic Surgery	GEN	1	Repackager or relabeler	accessdata.fda.gov
Gauge, Depth	HTJ	1	Repackager or relabeler	accessdata.fda.gov
Impactor	HWA	1	Repackager or relabeler	accessdata.fda.gov
Instrument, Manual, Surgical, General Use	MDM	1	Repackager or relabeler	accessdata.fda.gov
Instrument, Microsurgical	GZX	1	Repackager or relabeler	accessdata.fda.gov
Instrument, Surgical, Non-Powered	HAO	1	Repackager or relabeler	accessdata.fda.gov
Mallet, Surgical, General & Plastic Surgery	GFJ	1	Repackager or relabeler	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Repackager or relabeler	accessdata.fda.gov
Retractor	GAD	1	Repackager or relabeler	accessdata.fda.gov
Retractor, Self-Retaining	FFO	1	Repackager or relabeler	accessdata.fda.gov
Rongeur	HTX	1	Repackager or relabeler	accessdata.fda.gov
Scissors, General, Surgical	LRW	1	Repackager or relabeler	accessdata.fda.gov
Trocar, Ent	KTE	1	Repackager or relabeler	accessdata.fda.gov
Trocar, Sinus	KBG	1	Repackager or relabeler	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
October 8, 2019	K182773	Single-Use Non-Stick Bipolar forceps Bayonet, Single-Use Non-Stick Bipolar Irrigating forceps, Single Use Non-Stick Bipolar Suction forceps	GEI	Substantially Equivalent	Faulhaber Pinzetten Ohg	accessdata.fda.gov
May 10, 2013	K123478	STINGRAY BIPOLAR FORCEPS	GEI	Substantially Equivalent	Stingray Surgical Products	accessdata.fda.gov

Compare with other makers

Updated October 8, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.