# Coopersurgical, Inc. (manufacturer, Trumbull, CT): 14 new FDA device listings, incl. speculum, vaginal, nonmetal

**Score:** 95/100

| Field | Value |
|---|---|
| Establishment | Coopersurgical, Inc. |
| Role | Manufacturer |
| Establishment types | Complaint File Establishment per 21 CFR 820.198; Develop Specifications But Do Not Manufacture At This Facility; Manufacture Medical Device |
| Location | Trumbull, CT, US |
| New listings | 14 |
| Devices | Speculum, Vaginal, Nonmetal; Laparoscope, Gynecologic (And Accessories); Endoscope Channel Accessory; Hysteroscope (And Accessories); Media, Reproductive; Catheter And Tip, Suction; Fetal Head Elevator; Anoscope And Accessories; Accessory, Assisted Reproduction; Pessary, Vaginal |
| Product codes | HIB, HET, ODC, HIH, MQL, JOL, PWB, FER, MQG, HHW, GAD |
| Device classes | Class I, Class II |
| Medical specialties | Obstetrics/Gynecology, Gastroenterology, Urology, General Hospital, General, Plastic Surgery |
| Brand names | C020510 - HER SPEC Medium, Non-Sterile; C020600 - HER-Spec Small, Sterile; C020620 - HER-Spec Large, Sterile; C020130-1 - ER SPEC XSMALL, Non-Sterile; C020610 - HER-Spec Medium, Sterile; C020120-1 - ER SPEC Large, Non-Sterile; C020300 - ER-Spec Small, Sterile; C020310 - ER-Spec Medium, Sterile |
| First new listing | 2026-06-16 |
| Latest new listing | 2026-10-20 |
| FDA registration number | 1216677 |
| Registration expires | 2027-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- U.S. establishment.
- Listed in the last 45 days.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-11-04T21:52:36.524Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.