Data / Medical devices / United States / Minerva Surgical, Inc.

Minerva Surgical, Inc.: FDA-registered device maker in Santa Clara, CA, United States, 4 510(k) clearances and 2 PMA approvals

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

Minerva Surgical, Inc. is registered with the FDA (registration 3011011193) in Santa Clara, CA, United States. It lists 7 device types. The FDA files 4 510(k) clearances and 2 PMA approvals under its listings, the newest dated January 17, 2024. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3011011193
Address: 4255 Burton Drive, Santa Clara, CA, United States, 95054
Owner or operator: Minerva Surgical (10049783)
Roles: Manufacturer, Remanufacturer
First device listed: July 28, 2015
Registered through: 2026

Devices it lists

Device	Product code	Class	Role	Source
Device, Thermal Ablation, Endometrial	MNB	3	Manufacturer	accessdata.fda.gov
Dilator, Cervical, Fixed Size	HDQ	1	Manufacturer	accessdata.fda.gov
Hysteroscope (And Accessories)	HIH	2	Manufacturer	accessdata.fda.gov
Hysteroscope Accessories	NWW	1	Manufacturer	accessdata.fda.gov
Insufflator, Hysteroscopic	HIG	2	Manufacturer	accessdata.fda.gov
Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar	PGT	2	Manufacturer, Remanufacturer	accessdata.fda.gov
Stand, Infusion	FOX	1	Manufacturer	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
January 17, 2024	K233710	Symphion Operative Hysteroscopy System	PGT	Substantially Equivalent	Minerva Surgical, Inc.	accessdata.fda.gov
January 16, 2020	K191538	Resectr Tissue Resection Device	HIH	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
June 14, 2016	K160751	Symphion Endoscope and Symphion Cervical Sheath	HIH	Substantially Equivalent	Boston Scientific	accessdata.fda.gov
August 29, 2014	K141848	IOGYN SYSTEM	PGT	Substantially Equivalent	Iogyn, Inc.	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
July 27, 2015	P140013	MINERVA ENDOMETRIAL ABLATION SYSTEM	MNB	17	February 12, 2026	accessdata.fda.gov
April 20, 2001	P000040	HYDRO THERMABLATOR ENDOMETRIAL ABLATION SYSTEM	MNB	42	May 26, 2022	accessdata.fda.gov

Compare with other makers

Updated February 12, 2026. 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.