← Product Code [HNX](/submissions/OP/subpart-e%E2%80%94surgical-devices/HNX) · K951702

# FMS HIGH FLOW ARTHRO-SHEATH (K951702)

_Future Medical Systems, Inc. · HNX · May 12, 1995 · Ophthalmic · SN_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HNX/K951702

## Device Facts

- **Applicant:** Future Medical Systems, Inc.
- **Product Code:** [HNX](/submissions/OP/subpart-e%E2%80%94surgical-devices/HNX.md)
- **Decision Date:** May 12, 1995
- **Decision:** SN
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.4350
- **Device Class:** Class 1
- **Review Panel:** Ophthalmic

## Regulatory Identification

A manual ophthalmic surgical instrument is a nonpowered, handheld device intended to aid or perform ophthalmic surgical procedures. This generic type of device includes the manual corneal burr, ophthalmic caliper, ophthalmic cannula, eyelid clamp, ophthalmic muscle clamp, iris retractor clip, orbital compressor, ophthalmic curette, cystotome, orbital depressor, lachrymal dilator, erisophake, expressor, ophthalmic forcep, ophthalmic hook, sphere introducer, ophthalmic knife, ophthalmic suturing needle, lachrymal probe, trabeculotomy probe, cornea-sclera punch, ophthalmic retractor, ophthalmic ring (Flieringa), lachrymal sac rongeur, ophthalmic scissors, enucleating snare, ophthalmic spatula, ophthalmic specula, ophthalmic spoon, ophthalmic spud, trabeculotome or ophthalmic manual trephine.

---

**Source:** [https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HNX/K951702](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HNX/K951702)

**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