Browse hierarchy: [Obstetrics/Gynecology (OB)](/submissions/OB) → [Subpart B — Obstetrical and Gynecological Diagnostic Devices](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices) → [21 CFR 884.1300](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/884.1300) → HES — Insufflator, Carbon-Dioxide, Uterotubal (And Accessories)

# HES · Insufflator, Carbon-Dioxide, Uterotubal (And Accessories)

_Obstetrics/Gynecology · 21 CFR 884.1300 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HES

## Overview

- **Product Code:** HES
- **Device Name:** Insufflator, Carbon-Dioxide, Uterotubal (And Accessories)
- **Regulation:** [21 CFR 884.1300](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/884.1300)
- **Device Class:** 2
- **Review Panel:** [Obstetrics/Gynecology](/submissions/OB)
- **3rd-party reviewable:** yes

## Identification

A uterotubal carbon dioxide insufflator and accessories is a device used to test the patency (lack of obstruction) of the fallopian tubes by pressurizing the uterus and fallopian tubes and filling them with carbon dioxide gas.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (13 of 13)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K140761](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HES/K140761.md) | KAHN UTERINE CANNULA, JARCHO UTERINE CANNULA, NEAL FALLOPIAN CANNULA | Carefusion 2200, Inc. | Apr 21, 2014 | SESE |
| [K000340](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HES/K000340.md) | HYSTALOG HSG CATHETER | Rocket Medical Plc | Apr 19, 2000 | SESE |
| [K903209](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HES/K903209.md) | MAXI-FLOW INSUFFLATOR TUBING SET W/FILTER | Adler Instrument Co. | Dec 21, 1990 | SESE |
| [K903208](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HES/K903208.md) | MAXI-FLOW INSUFFLATOR TUBING SET | Adler Instrument Co. | Dec 17, 1990 | SESE |
| [K904473](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HES/K904473.md) | KRONNER MANIPUJECTOR | Unimar, Inc. | Dec 14, 1990 | SESE |
| [K901413](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HES/K901413.md) | CORE DISPOSABLE INSUFFLATION TUBING | Core Dynamics, Inc. | Sep 24, 1990 | SESE |
| [K891290](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HES/K891290.md) | SHOLKOFF BALLOON HYSTEROSALPINGOGRAPHY CATHETER | Cook Ob/Gyn | May 23, 1989 | SESE |
| [K890869](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HES/K890869.md) | BARD HYSTEROSALPINGOGRAPHY CATHETERS | C.R. Bard, Inc. | Apr 25, 1989 | SESE |
| [K875137](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HES/K875137.md) | LAPAROFLATOR 3000, STANDARD AND ELECTRONIC | F.M. Wiest USA, Inc. | Mar 2, 1988 | SESE |
| [K873515](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HES/K873515.md) | UTERINE INJECTOR 2MM | Zinnanti Surgical Instruments, Inc. | Sep 29, 1987 | SESE |
| [K862310](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HES/K862310.md) | CABOT MEDICAL VARIABLE FLOW INSUFFLATOR | Cabot Medical Corp. | Aug 12, 1986 | SESE |
| [K844173](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HES/K844173.md) | FEMTEST | Bionexus, Inc. | Aug 14, 1985 | SESE |
| [K841682](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HES/K841682.md) | UTERINE INJECTOR 4.0MM | Humi Corp. | Jul 3, 1984 | SESE |

## Top Applicants

- Adler Instrument Co. — 2 clearances
- Bionexus, Inc. — 1 clearance
- C.R. Bard, Inc. — 1 clearance
- Cabot Medical Corp. — 1 clearance
- Carefusion 2200, Inc. — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HES](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HES)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com