Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011011193

FEI Number

3011011193

Entity Name

MINERVA SURGICAL, INC.

City/State/Country

Santa Clara, CA, US

Establishment Address

4255 Burton Drive, Santa Clara, CA 95054, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Minerva Surgical (Owner Number: 10049783)

Owner / Operator Contact Address

4255 Burton Drive, Santa Clara, CA 95054, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K233710

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2020-11-22
HDQ	Dilator, Cervical, Fixed Size	Obstetrics/Gynecology	Class 1	884.4530	2016-09-19
MNB	Device, Thermal Ablation, Endometrial	Unknown	Class 3	N/A	2015-07-28
PGT	Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar	Obstetrics/Gynecology	Class 2	884.1710	2020-11-22
NWW	Hysteroscope Accessories	Obstetrics/Gynecology	Class 1	884.1690	2020-11-22
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2020-11-22
HIG	Insufflator, Hysteroscopic	Obstetrics/Gynecology	Class 2	884.1700	2024-05-31
PGT	Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar	Obstetrics/Gynecology	Class 2	884.1710	2024-05-31

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Minerva Surgical

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K935716	KARL STORZ Endoscopy-America, Inc.	KARL STORZ FIXED MAGNIFICATION TELESCOPE/KS VARIABLE MAGNIFICATION TELESCOPE	1995-11-16
K905706	Circon Acmi	GYN-1500 HYSTEROSCOPIC INUFFLATOR	1991-02-28

Similar Registrations

Registration Number	Establishment Name	Location
3014407293	POLYGON MEDICAL, INC.	Manalapan, NJ, US
3028536560	ORIGYN MEDICAL TECHNOLOGY (HANGZHOU) CO., LTD	Hangzhou Zhejiang, CN
3015972753	STERISERVICE SP. Z O.O.	Czestochowa Slaskie, PL
9611612	PAJUNK GMBH MEDIZINTECHNOLOGIE	GEISINGEN Baden-Wurttemberg, DE
3033902430	OMEC THAI CO.,LTD.	Bang Bo District Samut Prakan, TH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011011193. Last updated year: 2026. Please use registration number 3011011193 when referencing this establishment in official correspondence.